NCT05320783

Brief Summary

In the present study, we intended to evaluate the effect of music intervention on postoperative pain, nausea, and comprehensive recovery quality in patients undergoing gynecological laparoscopic surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 16, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
Last Updated

April 11, 2022

Status Verified

April 1, 2022

Enrollment Period

2.1 years

First QC Date

March 15, 2022

Last Update Submit

April 6, 2022

Conditions

Quality of Recovery After General AnesthesiaPost Operative Pain

Outcome Measures

Primary Outcomes (2)

  • Recovery quality

    Patient-reported survery, quality of recovery 40 (QoR 40): sum scores range from 40 to 200 (40; poor \~ 200; excellent quality of recovery)

    At postoperative day, 1

  • Postoperative pain

    Numeric rating scale (NRS, 0-10)O; no pain \~ 10; the most severe pain

    36 hours after surgery

Study Arms (2)

music intervention

ACTIVE COMPARATOR

Headphone was placed on the each patient. The classical music was started to the patients with individual comfortable volume.

Other: music

control

PLACEBO COMPARATOR

Headphone was placed on the each patients, but the music player was not started.

Other: control

Interventions

musicOTHER

Classical music pre-selected was started to the patients with individual comfortable volume.

music intervention
controlOTHER

music player was not started.

control

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists (ASA) physical status classification I and II,
  • undergoing gynecological laparoscopic surgery

You may not qualify if:

  • Any hearing impairment,
  • Known psychiatric or memory disorder
  • Alcohol or analgesics abuse
  • Inability to complete quesationnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eun kyung Choi

Daegu, Korea (the Republic Of), 41944, South Korea

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 15, 2022

First Posted

April 11, 2022

Study Start

December 16, 2019

Primary Completion

January 14, 2022

Study Completion

March 16, 2022

Last Updated

April 11, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

Locations

KR(1)